Trial Search Results
ARrest RESpiraTory Failure From PNEUMONIA
This research study seeks to establish the effectiveness of a combination of an inhaled corticosteroid and a beta agonist compared to placebo for the prevention of acute respiratory failure (ARF) in hospitalized patients with pneumonia and hypoxemia.
Stanford is currently accepting patients for this trial.
Lead Sponsor:
Stanford University
Collaborator: National Institutes of Health (NIH)
Stanford Investigator(s):
Intervention(s):
- Drug: Inhaled budesonide and formoterol
- Drug: Inhaled placebo
Phase:
Phase 3
Eligibility
Inclusion Criteria:
- Severe Pneumonia defined as hospitalization for acute (< 7 days) onset of symptoms
(cough, sputum production, or dyspnea) and radiographic evidence of pneumonia by chest
radiograph or CT scan and evidence of systemic inflammation (temperature < 35oC or >
38oC or WBC > or < upper or lower limits for site or procalcitonin > 0.5 mcg/L), or
known current immunosuppression preventing inflammatory response.
and
- Hypoxemia defined as new requirement for supplemental oxygen with SpO2 < 90% on room
air, ≤ 96% on ≥ 2 L/min oxygen, or > 6L/min or NIV (regardless of SpO2) at enrollment.
and
- No clinical suspicion for COVID-19 pneumonia or confirmed negative test for SARS CoV2
infection.
Exclusion Criteria:
- Inability to obtain consent within 24 hours of presentation to emergency room
- Intubation (or impending intubation) prior to enrollment (This does not include those
patients receiving High flow nasal cannula (HFNC) oxygen or Noninvasive ventilation
(NIV) prior to enrollment)
- A condition requiring inhaled corticosteroids or beta-agonists, or chronic systemic
steroid therapy equivalent to a dose >10 mg prednisone (this does not include patients
receiving inhaled beta-agonists in the Emergency Department without an established
indication if treating clinician is willing to discontinue subsequent treatments)
- Chronic lung or neuromuscular disease requiring daytime oxygen or mechanical
ventilation other than for obstructive sleep apnea (OSA) or obesity hypoventilation
syndrome
- Not anticipated to survive > 48 hours or not expected to require > 48 hours of
hospitalization
- Contraindication or known allergy to inhaled corticosteroids or beta-agonists
- Patients with heart rate > 130 bpm, ventricular tachycardia or new supraventricular
tachycardia within last 4 hours will be potentially eligible for enrollment after the
condition has resolved
- Patients with K+ < 3.0 will be potentially eligible for enrollment after the condition
has resolved
- Patient not committed to full support other than intubation or resuscitation (i.e.,
DNR/DNI status allowed)
- Pregnancy
- Incarcerated individual
- Physician refusal of consent to protocol
- Patient/surrogate refusal of consent to protocol
Ages Eligible for Study
18 Years - N/A
Genders Eligible for Study
All
Now accepting new patients
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Joe Levitt, MD
650-723-6381